
Thermoelastic Technologies, Inc.
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BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 is an FDA 510(k)-cleared medical device (K012882) manufactured by Thermoelastic Technologies, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2001. Regulation: 8.